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Optimization of Diagnostic Instruments for Migraine – Project II

Optimization of Diagnostic Instruments for Migraine – Project II - ODIN-Migraine II

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034834
Enrollment
128
Registered
2024-08-12
Start date
2024-11-18
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G43

Interventions

Group 1: Routine inpatient treatment at the Migraine and Headache Clinic Königstein

Sponsors

Psychologisches Institut der Johannes Gutenberg-Universität Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Diagnosed migraine (episodic migraine with/without aura or chronic migraine) according to criteria 1.1, 1.2, 1.3 of the International Classification of Headache Disorders (ICHD-3, 3rd Edition, 2018, Headache Classification Committee of the International Headache Society, IHS). • Current treatment at the Migraine and Headache Clinic Königstein. • Duration of disease of at least 12 months.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Scale sum of each the Migraine Interictal Burden Scale (MIBS-4, German version, Buse et al., 2007) and the Cogniphobia Scale for Headache Disorders (CS-HD, German version, Klan et al., 2024)

Secondary

MeasureTime frame
• To determine convergent validity, the values of the following established questionnaires are recorded: (i) Headache Impact Test (HIT-6™, Gandek et al., 2003, Kosinski et al., 2003), (ii) Depression, Anxiety and Stress Scales (DASS, Nilges & Essau, 2015), (iii) short form of the Headache Triggers Sensitivity and Avoidance Questionnaire (HTSAQ-SF-G, Caroli et al, 2020), (iv) short form of the Headache Management and Self-Efficacy Scale (HMSE-G-SF, Graef et al., 2015), (v) Fear of Attacks in Migraine Inventory (FAMI, Klan et al., 2022). • As a further approach to determine the convergent validity, the following clinical parameters are collected: (i) migraine days in the past four weeks, (ii) days with acute migraine medication in the past four weeks. • To determine divergent validity, the openness scale of the NEO Five Factor Inventory (NEO-FFI-30, German 30-item short form, Körner et al., 2015) is recorded. • To determine the criterion-based sensitivity to change, the subjective improvement experienced by the patients is recorded (numerical rating scale 1 to 7, with 1 = strong deterioration, 2 = medium deterioration, 3 = slight deterioration, 4 = no change, 5 = slight improvement, 6 = medium improvement, 7 = strong improvement). • To establish an empirical cut-off value, a comparison with self-reported disability is intended (based on the scale for clinical assessments and diagnoses of the Diagnostic Interview in Psychological Disorders [DIPS Open Access 1.2, Margraf et al., 2021], a scale value = 4 is defined as clinically relevant disability).

Countries

Germany

Contacts

Public ContactTimo Klan

Psychologisches Institut der Johannes Gutenberg-Universität Mainz

klan@uni-mainz.de+4961313939112

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026